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Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects of non-childbearing potential between the ages of
21 and 55 years, inclusive.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.

- 12-lead ECG demonstrating QTc >450 msec at screening.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half-lives preceding the first dose of study
medication.

- History of orthostatic symptoms or orthostatic hypotension at screening.

- Pregnant or nursing females; females of childbearing potential.

NCT01140425
Pfizer
Completed
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

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Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects
The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: PF-00232798
    600 mg oral solution once daily x 7 days
  • Drug: PF-00232798
    300 mg oral solution once daily x 7 days
  • Drug: Placebo
    Oral solution once daily x 7 days
  • Drug: Moxifloxacin
    400 mg tablet single dose
  • Experimental: PF-00232798 supratherapeutic dose
    PF-00232798 supratherapeutic dose
    Intervention: Drug: PF-00232798
  • Experimental: PF-00232798 therapeutic dose
    PF-00232798 therapeutic dose
    Intervention: Drug: PF-00232798
  • Placebo Comparator: Placebo for PF-00232798
    Placebo for PF-00232798
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin
    Moxifloxacin
    Intervention: Drug: Moxifloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • 12-lead ECG demonstrating QTc >450 msec at screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • History of orthostatic symptoms or orthostatic hypotension at screening.
  • Pregnant or nursing females; females of childbearing potential.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01140425
A7691017
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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